FDAAugust 16, 2019device
REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The femoral impactors have a higher than normal risk of the arm breaking. During impaction the tip of the arm may fracture and separate from the instrument. This may cause a minor delay in surgery. If not retrieved, it may cause an inflammatory response that may require revision surgery.
What to do
FDA enforcement status: Terminated
Brands named
enztec
UPCs
09421028110624
Recall history
No related federal recalls on record for this brand yet.
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